Feasibility and Acceptability of an Online ACT Intervention for Disorders of Gut-Brain Interaction
NCT ID: NCT06887751
Last Updated: 2025-04-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
30 participants
INTERVENTIONAL
2025-03-19
2025-08-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
What are the perceptions of patients with DGBI and healthcare practitioners regarding the acceptability, feasibility, and usability of the iACTforDGBI intervention?
Participants will be asked to:
Complete the iACTforDGBI intervention prototype, consisting of self-guided online sessions.
Participate in online interviews and fill out online questionnaires to evaluate the intervention concerning acceptability, feasibility, usability and preliminary effects.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Feasibility and Acceptability of an Online ACT Intervention for Disorders of Gut-Brain Interaction - Beta Trial
NCT07175402
Development of an Online ACT Intervention for Disorders of Gut-Brain Interaction
NCT06309004
Psychological Treatment in Psychiatric Inpatient Care.
NCT06702254
Study Protocol for a Feasibility Study of a Novel ACT-based eHealth Psychoeducational Intervention for Students With Mental Distress
NCT03810131
Patient-driven Internet Delivered Psychological Treatment
NCT04688567
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Acceptance and Commitment Therapy (ACT)
Acceptance and Commitment Therapy (ACT)
Acceptance and Commitment Therapy (ACT)
The self-guided Online version of Acceptance and Commitment Therapy (iACTforDGBI) intervention will include 8 weekly sessions of around 20 minutes each, and will comprise ACT-consistent informative texts, audio exercises, and videos.
The intervention is expected to have the following overall structure: Session 1: Introduction to the intervention and promotion of creative hopelessness, Awareness of bodily sensations, Values clarification Session 2: Committed action, Acceptance, Cognitive defusion Session 3: Self as context, Conclusions Session 4-8: personalised content (in-depth material and tasks based on individual difficulties assessed with diary)
Psychoeducation
Psychoeducation
Psychoeducation
Participants in the active control group will be asked to complete 8 weekly 20-minute sessions of an online course for education on DGBIs. This course will be delivered through a similar platform than the one delivering the online ACT for DGBI intervention, via the same website. The intervention platform will have similar designs and structure, and will be developed by the same web development company.
The content of the education course will be based on the IBS school intervention (e.g., Ringström et al., 2009), in particular its online version (Lindfors et al., 2021), developed by members of the current research team. This education intervention was based on the biopsychosocial model of DGBI and was originally developed and tested as a face-to-face group intervention with six 2-h sessions held weekly. IBS school generally aims at increasing disease knowledge in people with IBS and covers a wide spectrum of issues related to IBS, such as disease pathophysiological me
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Acceptance and Commitment Therapy (ACT)
The self-guided Online version of Acceptance and Commitment Therapy (iACTforDGBI) intervention will include 8 weekly sessions of around 20 minutes each, and will comprise ACT-consistent informative texts, audio exercises, and videos.
The intervention is expected to have the following overall structure: Session 1: Introduction to the intervention and promotion of creative hopelessness, Awareness of bodily sensations, Values clarification Session 2: Committed action, Acceptance, Cognitive defusion Session 3: Self as context, Conclusions Session 4-8: personalised content (in-depth material and tasks based on individual difficulties assessed with diary)
Psychoeducation
Participants in the active control group will be asked to complete 8 weekly 20-minute sessions of an online course for education on DGBIs. This course will be delivered through a similar platform than the one delivering the online ACT for DGBI intervention, via the same website. The intervention platform will have similar designs and structure, and will be developed by the same web development company.
The content of the education course will be based on the IBS school intervention (e.g., Ringström et al., 2009), in particular its online version (Lindfors et al., 2021), developed by members of the current research team. This education intervention was based on the biopsychosocial model of DGBI and was originally developed and tested as a face-to-face group intervention with six 2-h sessions held weekly. IBS school generally aims at increasing disease knowledge in people with IBS and covers a wide spectrum of issues related to IBS, such as disease pathophysiological me
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Meeting clinical symptom levels for least one DGBI diagnosis (assessed with the Rome IV Diagnostic Questionnaire for Functional Gastrointestinal Disorders in Adults (Palsson et al., 2016))
3. Clinically meaningful levels of depressive symptoms or anxiety: score ≥ 13 on the Montgomery Åsberg Depression Rating Scale (Svanborg \& Åsberg, 1994; (MADRS-S; depressive symptoms), or score ≥ 10 on the Generalized Anxiety Disorder scale-7 (GAD-7; anxiety symptoms; Spitzer et al., 2006)
4. Stable medication for psychiatric symptoms including anxiety, depression and sleep problems for at least two months prior to intervention.
5. Ability to read and write Swedish
6. Have access to a device (like computer, tablet or smartphone with) with access to the internet and that can be used to attend video conferences and preview the intervention platform (i.e., have a microphone and speakers or headphones).
Exclusion Criteria
2. Increased risk of suicide (≥4 points on MADRS item 9)
3. Severe depression (\>34 points on MADRS)
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sahlgrenska University Hospital
OTHER
Göteborg University
OTHER
Uppsala University
OTHER
Örebro University, Sweden
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Örebro University
Örebro, , Sweden
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2023-00741b
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.